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AtroventHFA

Atrovent HFA (ipratropium bromide HFA) Inhalation Aerosol

Approved
Approval ID

b37e86c4-9af4-4278-baa9-d66bb3fb66d6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 28, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ipratropium bromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5511
Application NumberNDA021527
Product Classification
M
Marketing Category
C73594
G
Generic Name
ipratropium bromide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 22, 2010
FDA Product Classification

INGREDIENTS (5)

IPRATROPIUM BROMIDEActive
Quantity: 17 ug in 1 1
Code: J697UZ2A9J
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT

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AtroventHFA - FDA Drug Approval Details